Surgical Site InfectionPhase 4POSSIBLENCT06338163
Polihexanide SSIs Measures Bundle (PSMB) During Enhanced Recovery After Major Digestive Surgery
A Phase 4 study testing Polihexanide-based bundle and Standard bundle in people with Surgical Site Infection and Surgical Procedures, Operative, run by Marco Catarci at 3 sites in Italy.
Trial summary
This is a randomized controlled, prospective, multicenter superiority trial with two parallel treatment groups and single blinding (local investigators performing postoperative follow up will be blinded for group allocation), with prospective enrollment planned from July 2024 to June 2025 in 20 Italian surgical… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Site Infection, Surgical Procedures, Operative
- What is being tested?
- Polihexanide-based bundle and Standard bundle
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 3 sitesItaly
- Study dates
- 1 Jul 2024to 30 Sep 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients submitted to laparoscopic/robotic/open/converted major digestive surgery (upper and lower gastrointestinal resections).
- American Society of Anesthesiologists' (ASA) class I, II, III or IV
- Elective surgery
- Patients' written acceptance to be included in the study.
Who cannot join
- American Society of Anesthesiologists' (ASA) class V
- Urgent surgery
- Pregnancy
- Hyperthermic intraperitoneal chemotherapy for carcinomatosis.
Trial locations and contacts
3 sites in 1 country.
Italy3 sites
OSpedale Santa Maria Annunziata
Florence, FI, 50012
Marco Scatizzi, MD, 393474137246, marcoscatizzi@gmail.com
Ospedale Civile di Macerata
Province of Macerata, MC, 62100
Massimo Sartelli, MD, +393405369701, massimosartelli@gmail.com
Ospedale Sandro Pertini
Roma, RM, 00157
Marco Catarci, MD, +393298610040, marco.catarci@aslroma2.it
Michele Benedetti, MD
About this study
This is a randomized controlled, prospective, multicenter superiority trial with two parallel treatment groups and single blinding (local investigators performing postoperative follow up will be blinded for group allocation), with prospective enrollment planned from July 2024 to June 2025 in 20 Italian surgical centers. All patients undergoing elective major gastro-intestinal (GI) tract surgery (upper GI, HPB, \& lower GI) will be included in a prospective database after written informed consent. A total of 2,000 patients is expected based on a mean of 100 cases per center.
Read the detailed description
Just after signing a written informed consent to participate, patients will randomly be assigned either to the experimental group (Polihexanide bundle) or to the control group. Block randomization (blocks of 10 patients per single participating center) will be performed using an unstratified computer generated randomization list. All operations will be performed according to local criteria of the participating center. Hair removal will be accomplished on the day of surgery with electronic clippers. Alcohol-based solutions of chlorhexidine for surgical site skin preparation will be used. A first dose of perioperative i.v. antibiotics will be administered 30 minutes before skin incision (choice of the antibiotic according to local criteria) in all patients. Additional intraoperative doses will be administered for procedures exceeding two half-lives of the antibiotic. At the end of the operation, the peritoneal cavity will be rinsed routinely with 0.9% sodium chloride solution (normal saline, NS) at body temperature. Before closure of fascia, instruments and gloves will be changed. The eventual placement of drain(s) in the peritoneal cavity and/or creation of an intestinal stoma will be recorded. No subcutaneous suture or drainage will be done. Skin will be closed with either staples, intracutaneous running suture or interrupted sutures.
Potential patient-specific and intraoperative risk factors will be recorded: sex, age, body mass index, nutritional status, frailty, indication to surgery (benign vs. malignant disease), perioperative administration of steroids, renal failure and dialysis, cardiovascular or respiratory disease, American Society of Anesthesiologist class, bowel preparation, type of approach, operative time, presence of peritoneal cavity drainage. During the postoperative period, patients will be examined by the attending surgeon daily. Fever (central temperature > 38 °C), pulse, abdominal signs, bowel movements, volume and aspect of drainage (if present) will be recorded daily. The local attending surgeon will make any decision for complementary exams and imaging according to his own criteria. The rate of any adverse event will be calculated and graded according to the Clavien-Dindo criteria [19] and to Japan Clinical Oncology Group Postoperative Complications (JCOG-PC) extended criteria [20], including all anastomotic leaks, wound infection (according to the definitions of the Centers for Disease Control and Prevention and wound culture), pneumonia (clinical symptoms, and physical and radiological examinations), central venous line infection (positive blood culture), urinary tract infection (positive urine culture with bacterial count). ERAS pathway items will be defined according to national [27] guidelines, measuring adherence upon explicit criteria. All data will be recorded for a minimum of 8 weeks (60 days) after surgery. PROM questionnaires will be administered to all enrolled patients four to one week before the planned operation, at discharge, and 6 to 8 weeks after the operation.
After anonymization, all data of each single case will be prospectively uploaded by local investigator(s) on a web-based database, protected by individual access credentials, and incorporated into a spreadsheet for data analysis. Any eventual discrepancy and/or mismatch will be checked, addressed and solved through strict cooperation between coordinating and local investigators.
- Being tested
- Polihexanide-based bundle, Standard bundle
- Keywords
- surgical site infection, polihexanide, preoperative decontamination
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polihexanide-based bundleCombination product
Also called Prontoderm® Wipes (B. Braun Medical AG, Sempach, Switzerland), Prontoderm® Nasal Gel (B. Braun Medical AG, Sempach, Switzerland), ProntOral® (B. Braun Medical AG, Sempach, Switzerland), LavaSurge® (B. Braun Medical AG, Sempach, Switzerland)
Pre- and intra-operative decontamination will be accomplished in the treatment (experimental) arm with Polihexanide-based products
Standard bundleCombination product
Pre- and intra-operative decontamination will be accomplished in the control arm with normal soap/shampoo and saline solution
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Once a day starting 5 days before the operation:
Total body washing with usual soap/shampoo and single-use washcloths impregnated with a mix of Polihexanide, surfactants, and excipients.
Nasal cleaning 3 times a day with a Polihexanide Nasal Gel Oral gargles 3 times a day using 10 mL of a Polihexanide oral solution. After the closure of fascia, 10 minutes subcutaneous irrigation with 50 to 250 mL (according to incision length) of antiseptic solution will be performed using a 0.04% sterile Polihexanide solution. After the end of the application time, a subcutaneous swab for culture will be taken. Before standard (according to local center clinical practice) wound(s) dressing(s), a 3 mm-thick antiseptic gel (a combination comprised of 0.1 % Polihexanide and 0.1 % propyl betaine (surfactant) that is used for cleansing, moistening and decontamination of post-operative wounds) will be applied on any wound(s). Receives: Combination Product: Polihexanide-based bundle |
| Control | Active comparator | Once a day starting 5 days before the operation:
Total body washing with usual soap/shampoo. No oral and nasal MDRO-decolonization will be performed. After the closure of fascia, 10 minutes subcutaneous irrigation with 50 to 250 mL (according to incision length) NS will be performed. After the end of the application time, a subcutaneous swab for culture will be taken. Finally, standard wound(s) dressing(s) (according to local center clinical practice) will be applied. Receives: Combination Product: Standard bundle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Site Infections rate
CDC definition
Measured: 60 days after surgery
Incisional (superficial and deep) Surgical Site Infections rate
CDC definition
Measured: 60 days after surgery
Infectious morbidity rates
SSI + urinary tract infection + pulmonary infection
Measured: 60 days after surgery
Secondary outcomes (6)
Anastomotic leakage rates
According to international consensus
Measured: 60 days after surgery
Overall morbidity rates
Any adverse event
Measured: 60 days after surgery
Major morbidity rates
Any adverse event grade > II according to Clavien-Dindo
Measured: 60 days after surgery
Comprehensive complication index
According to Slankamenac et al 2013
Measured: 60 days after surgery
Overall length of postoperative hospital stay
inclusive of any unplanned readmission
Measured: 60 days after surgery
Readmission rates
any unplanned readmission after primary discharge
Measured: 60 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2024
- Study start1 Jul 2024 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Surgical Site InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled prospective multicenter
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marco Catarci
- Sponsor type
- University, hospital or other
- Collaborators
- Associazione Chirurghi Ospedalieri Italiani
- Responsible party
- Sponsor-investigator, Marco Catarci, Ospedale Sandro Pertini, Roma
- Investigators
- Marco Catarci, MD, FACS, Study chair, Associazione Chirurghi Ospedalieri ItalianiMassimo Sartelli, MD, Principal investigator, Ospedale di Macerata
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06338163
- Sponsor's protocol ID
- POSSIBLE 1.6
- Acronym
- POSSIBLE
- Status last verified
- Apr 2024
- First submitted
- 23 Mar 2024
- Last updated
- 4 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: complete dataset after study completion will be availble upon request
Publications
Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibanes E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009 Aug;250(2):187-96. doi: 10.1097/SLA.0b013e3181b13ca2.
PubMed 19638912Katayama H, Kurokawa Y, Nakamura K, Ito H, Kanemitsu Y, Masuda N, Tsubosa Y, Satoh T, Yokomizo A, Fukuda H, Sasako M. Extended Clavien-Dindo classification of surgical complications: Japan Clinical Oncology Group postoperative complications criteria. Surg Today. 2016 Jun;46(6):668-85. doi: 10.1007/s00595-015-1236-x. Epub 2015 Aug 20.
PubMed 26289837Strobel RM, Leonhardt M, Krochmann A, Neumann K, Speichinger F, Hartmann L, Lee LD, Beyer K, Daum S, Kreis ME, Lauscher JC. Reduction of Postoperative Wound Infections by Antiseptica (RECIPE)?: A Randomized Controlled Trial. Ann Surg. 2020 Jul;272(1):55-64. doi: 10.1097/SLA.0000000000003645.
PubMed 31599810Rahbari NN, Weitz J, Hohenberger W, Heald RJ, Moran B, Ulrich A, Holm T, Wong WD, Tiret E, Moriya Y, Laurberg S, den Dulk M, van de Velde C, Buchler MW. Definition and grading of anastomotic leakage following anterior resection of the rectum: a proposal by the International Study Group of Rectal Cancer. Surgery. 2010 Mar;147(3):339-51. doi: 10.1016/j.surg.2009.10.012. Epub 2009 Dec 11.
PubMed 20004450Allegranzi B, Bischoff P, de Jonge S, Kubilay NZ, Zayed B, Gomes SM, Abbas M, Atema JJ, Gans S, van Rijen M, Boermeester MA, Egger M, Kluytmans J, Pittet D, Solomkin JS; WHO Guidelines Development Group. New WHO recommendations on preoperative measures for surgical site infection prevention: an evidence-based global perspective. Lancet Infect Dis. 2016 Dec;16(12):e276-e287. doi: 10.1016/S1473-3099(16)30398-X. Epub 2016 Nov 2.
PubMed 27816413Berrios-Torres SI, Umscheid CA, Bratzler DW, Leas B, Stone EC, Kelz RR, Reinke CE, Morgan S, Solomkin JS, Mazuski JE, Dellinger EP, Itani KMF, Berbari EF, Segreti J, Parvizi J, Blanchard J, Allen G, Kluytmans JAJW, Donlan R, Schecter WP; Healthcare Infection Control Practices Advisory Committee. Centers for Disease Control and Prevention Guideline for the Prevention of Surgical Site Infection, 2017. JAMA Surg. 2017 Aug 1;152(8):784-791. doi: 10.1001/jamasurg.2017.0904.
PubMed 28467526Mueller TC, Loos M, Haller B, Mihaljevic AL, Nitsche U, Wilhelm D, Friess H, Kleeff J, Bader FG. Intra-operative wound irrigation to reduce surgical site infections after abdominal surgery: a systematic review and meta-analysis. Langenbecks Arch Surg. 2015 Feb;400(2):167-81. doi: 10.1007/s00423-015-1279-x. Epub 2015 Feb 14.
PubMed 25681239
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polihexanide SSIs Measures Bundle (PSMB) During Enhanced Recovery After Major Digestive Surgery
- ClinicalTrials.gov ID
- NCT06338163
- Acronym / sponsor ID
- POSSIBLE / POSSIBLE 1.6
- Keywords
- surgical site infection, polihexanide, preoperative decontamination
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Marco CatarciUniversity, hospital or other
- Collaborators
- Associazione Chirurghi Ospedalieri Italiani
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 29 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized controlled, prospective, multicenter superiority trial with two parallel treatment groups and single blinding (local investigators performing postoperative follow up will be blinded for group allocation), with prospective enrollment planned from July 2024 to June 2025 in 20 Italian surgical centers. All patients undergoing elective major gastro-intestinal (GI) tract surgery (upper GI, HPB, \& lower GI) will be included in a prospective database after written informed consent. A total of 2,000 patients is expected based on a mean of 100 cases per center.
Detailed description
Just after signing a written informed consent to participate, patients will randomly be assigned either to the experimental group (Polihexanide bundle) or to the control group. Block randomization (blocks of 10 patients per single participating center) will be performed using an unstratified computer generated randomization list. All operations will be performed according to local criteria of the participating center. Hair removal will be accomplished on the day of surgery with electronic clippers. Alcohol-based solutions of chlorhexidine for surgical site skin preparation will be used. A first dose of perioperative i.v. antibiotics will be administered 30 minutes before skin incision (choice of the antibiotic according to local criteria) in all patients. Additional intraoperative doses will be administered for procedures exceeding two half-lives of the antibiotic. At the end of the operation, the peritoneal cavity will be rinsed routinely with 0.9% sodium chloride solution (normal saline, NS) at body temperature. Before closure of fascia, instruments and gloves will be changed. The eventual placement of drain(s) in the peritoneal cavity and/or creation of an intestinal stoma will be recorded. No subcutaneous suture or drainage will be done. Skin will be closed with either staples, intracutaneous running suture or interrupted sutures.
Potential patient-specific and intraoperative risk factors will be recorded: sex, age, body mass index, nutritional status, frailty, indication to surgery (benign vs. malignant disease), perioperative administration of steroids, renal failure and dialysis, cardiovascular or respiratory disease, American Society of Anesthesiologist class, bowel preparation, type of approach, operative time, presence of peritoneal cavity drainage. During the postoperative period, patients will be examined by the attending surgeon daily. Fever (central temperature > 38 °C), pulse, abdominal signs, bowel movements, volume and aspect of drainage (if present) will be recorded daily. The local attending surgeon will make any decision for complementary exams and imaging according to his own criteria. The rate of any adverse event will be calculated and graded according to the Clavien-Dindo criteria [19] and to Japan Clinical Oncology Group Postoperative Complications (JCOG-PC) extended criteria [20], including all anastomotic leaks, wound infection (according to the definitions of the Centers for Disease Control and Prevention and wound culture), pneumonia (clinical symptoms, and physical and radiological examinations), central venous line infection (positive blood culture), urinary tract infection (positive urine culture with bacterial count). ERAS pathway items will be defined according to national [27] guidelines, measuring adherence upon explicit criteria. All data will be recorded for a minimum of 8 weeks (60 days) after surgery. PROM questionnaires will be administered to all enrolled patients four to one week before the planned operation, at discharge, and 6 to 8 weeks after the operation.
After anonymization, all data of each single case will be prospectively uploaded by local investigator(s) on a web-based database, protected by individual access credentials, and incorporated into a spreadsheet for data analysis. Any eventual discrepancy and/or mismatch will be checked, addressed and solved through strict cooperation between coordinating and local investigators.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled prospective multicenter
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Combination Product: Polihexanide-based bundleOnce a day starting 5 days before the operation: Total body washing with usual soap/shampoo and single-use washcloths impregnated with a mix of Polihexanide, surfactants, and excipients. Nasal cleaning 3 times a day with a Polihexanide Nasal Gel Oral gargles 3 times a day using 10 mL of a Polihexanide oral solution. After the closure of fascia, 10 minutes subcutaneous irrigation with 50 to 250 mL (according to incision length) of antiseptic solution will be performed using a 0.04% sterile Polihexanide solution. After the end of the application time, a subcutaneous swab for culture will be taken. Before standard (according to local center clinical practice) wound(s) dressing(s), a 3 mm-thick antiseptic gel (a combination comprised of 0.1 % Polihexanide and 0.1 % propyl betaine (surfactant) that is used for cleansing, moistening and decontamination of post-operative wounds) will be applied on any wound(s). |
| Control | Active comparator | Combination Product: Standard bundleOnce a day starting 5 days before the operation: Total body washing with usual soap/shampoo. No oral and nasal MDRO-decolonization will be performed. After the closure of fascia, 10 minutes subcutaneous irrigation with 50 to 250 mL (according to incision length) NS will be performed. After the end of the application time, a subcutaneous swab for culture will be taken. Finally, standard wound(s) dressing(s) (according to local center clinical practice) will be applied. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients submitted to laparoscopic/robotic/open/converted major digestive surgery (upper and lower gastrointestinal resections).
- American Society of Anesthesiologists' (ASA) class I, II, III or IV
- Elective surgery
- Patients' written acceptance to be included in the study.
Key exclusion criteria (4 listed)
- American Society of Anesthesiologists' (ASA) class V
- Urgent surgery
- Pregnancy
- Hyperthermic intraperitoneal chemotherapy for carcinomatosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polihexanide-based bundleAlso: Prontoderm® Wipes (B. Braun Medical AG, Sempach, Switzerland), Prontoderm® Nasal Gel (B. Braun Medical AG, Sempach, Switzerland), ProntOral® (B. Braun Medical AG, Sempach, Switzerland), LavaSurge® (B. Braun Medical AG, Sempach, Switzerland)Pre- and intra-operative decontamination will be accomplished in the treatment (experimental) arm with Polihexanide-based products | Combination product | Treatment |
| Standard bundlePre- and intra-operative decontamination will be accomplished in the control arm with normal soap/shampoo and saline solution | Combination product | Control |
Primary outcome
Surgical Site Infections rate
Time frame: 60 days after surgery
CDC definition
Incisional (superficial and deep) Surgical Site Infections rate
Time frame: 60 days after surgery
CDC definition
Infectious morbidity rates
Time frame: 60 days after surgery
SSI + urinary tract infection + pulmonary infection
6 secondary outcomes
Anastomotic leakage rates
Time frame: 60 days after surgery
Overall morbidity rates
Time frame: 60 days after surgery
Major morbidity rates
Time frame: 60 days after surgery
Comprehensive complication index
Time frame: 60 days after surgery
Overall length of postoperative hospital stay
Time frame: 60 days after surgery
Readmission rates
Time frame: 60 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2024.
- Background: PubMed 19638912Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibanes E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009 Aug;250(2):187-96. doi: 10.1097/SLA.0b013e3181b13ca2.
- Background: PubMed 26289837Katayama H, Kurokawa Y, Nakamura K, Ito H, Kanemitsu Y, Masuda N, Tsubosa Y, Satoh T, Yokomizo A, Fukuda H, Sasako M. Extended Clavien-Dindo classification of surgical complications: Japan Clinical Oncology Group postoperative complications criteria. Surg Today. 2016 Jun;46(6):668-85. doi: 10.1007/s00595-015-1236-x. Epub 2015 Aug 20.
- Background: PubMed 31599810Strobel RM, Leonhardt M, Krochmann A, Neumann K, Speichinger F, Hartmann L, Lee LD, Beyer K, Daum S, Kreis ME, Lauscher JC. Reduction of Postoperative Wound Infections by Antiseptica (RECIPE)?: A Randomized Controlled Trial. Ann Surg. 2020 Jul;272(1):55-64. doi: 10.1097/SLA.0000000000003645.
- Background: PubMed 20004450Rahbari NN, Weitz J, Hohenberger W, Heald RJ, Moran B, Ulrich A, Holm T, Wong WD, Tiret E, Moriya Y, Laurberg S, den Dulk M, van de Velde C, Buchler MW. Definition and grading of anastomotic leakage following anterior resection of the rectum: a proposal by the International Study Group of Rectal Cancer. Surgery. 2010 Mar;147(3):339-51. doi: 10.1016/j.surg.2009.10.012. Epub 2009 Dec 11.
- Background: PubMed 27816413Allegranzi B, Bischoff P, de Jonge S, Kubilay NZ, Zayed B, Gomes SM, Abbas M, Atema JJ, Gans S, van Rijen M, Boermeester MA, Egger M, Kluytmans J, Pittet D, Solomkin JS; WHO Guidelines Development Group. New WHO recommendations on preoperative measures for surgical site infection prevention: an evidence-based global perspective. Lancet Infect Dis. 2016 Dec;16(12):e276-e287. doi: 10.1016/S1473-3099(16)30398-X. Epub 2016 Nov 2.
- Background: PubMed 28467526Berrios-Torres SI, Umscheid CA, Bratzler DW, Leas B, Stone EC, Kelz RR, Reinke CE, Morgan S, Solomkin JS, Mazuski JE, Dellinger EP, Itani KMF, Berbari EF, Segreti J, Parvizi J, Blanchard J, Allen G, Kluytmans JAJW, Donlan R, Schecter WP; Healthcare Infection Control Practices Advisory Committee. Centers for Disease Control and Prevention Guideline for the Prevention of Surgical Site Infection, 2017. JAMA Surg. 2017 Aug 1;152(8):784-791. doi: 10.1001/jamasurg.2017.0904.
- Background: PubMed 25681239Mueller TC, Loos M, Haller B, Mihaljevic AL, Nitsche U, Wilhelm D, Friess H, Kleeff J, Bader FG. Intra-operative wound irrigation to reduce surgical site infections after abdominal surgery: a systematic review and meta-analysis. Langenbecks Arch Surg. 2015 Feb;400(2):167-81. doi: 10.1007/s00423-015-1279-x. Epub 2015 Feb 14.
- Individual participant dataSharing planned: Undecided. complete dataset after study completion will be availble upon request
Related trials for Surgical Site Infection
Not yet recruitingObservational study
Arterial Stiffness During Negative Pressure Wound Therapy for Abdominal Wall Wounds
Postoperative Abdominal Wall Wound Complications, Surgical Wound Infection
Not yet recruiting
Povidone-Iodine and Ozonated Distilled Water Irrigation in the Management of Maxillofacial Space Infections
Infection, Surgical Site
Not yet recruiting
Suture Choice for Ostomy Creation
Ostomy - Ileostomy or Colostomy, Stoma Complications
Not yet recruitingPhase 3
Evaluation of the Effect of Antibiotic Prophylaxis During Lumpectomy for Breast Cancer: Prospective Randomised Double-blind Noninferiority Study of Placebo vs Cefazolin
Breast Cancer, Breast Surgery
RecruitingPhase 3
Steroids for Facial Nerve Function Protection in Post-surgical Vestibular Schwannoma Patients
Vestibular Schwannoma, Facial Nerve Paralysis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marco Catarci, MD, FACS study chair
Associazione Chirurghi Ospedalieri Italiani
Massimo Sartelli, MD principal investigator
Ospedale di Macerata
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Polihexanide-based bundle and Standard bundle in people with Surgical Site Infection and Surgical Procedures, Operative, run by Marco Catarci at 3 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marco Scatizzi, MD (+393492197687, marcoscatizzi60@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical Site Infections rate (time frame: 60 days after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06338163, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2024.